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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K142077
Device Name MYLABGAMMA
Applicant
Esaote, S.P.A.
9001 Wesleyan Rd.
Suite 200
Indianpolis,  IN  46268
Applicant Contact Allison Scott
Correspondent
Esaote, S.P.A.
9001 Wesleyan Rd.
Suite 200
Indianpolis,  IN  46268
Correspondent Contact Allison Scott
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/31/2014
Decision Date 09/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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